FDA.reportPublic FDA data

Clarithromycin

Product NDC
55648-949
11-digit product format
556480949
Labeler code
55648
Product ID
55648-949_33ad64a4-7952-474e-baad-0c6f7528d06a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clarithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Wockhardt Limited
Application
ANDA065266
Marketing category
ANDA
Marketing start
2006-05-31
Marketing end
0000-00-00
Substance
CLARITHROMYCIN
Active strength
500 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2bb254ff-3d7f-4bdb-abf9-476506008c55Product name120230117
e3d1ac4d-bee8-bcec-c4e6-12004dcb6ab2Product name720221114
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55648-949-012019-11-27C16284748780-19855d018-d6c1-cd31-e053-dbdaa90ab51aCLARITHROMYCIN TABLETS, USP
55648-949-022019-11-27C16284748780-19855d018-d6c1-cd31-e053-dbdaa90ab51aCLARITHROMYCIN TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55648-949-01Clarithromycin60 in 1 BOTTLETABLET, FILM COATED602
55648-949-02Clarithromycin1200 in 1 POUCHTABLET, FILM COATED12002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLARITHROMYCINACTIVE INGREDIENTH1250JIK0ACLARITHROMYCIN TABLET, FILM COATED [WOCKHARDT LIMITED]2
CLARITHROMYCINACTIVE MOIETYH1250JIK0ACLARITHROMYCIN TABLET, FILM COATED [WOCKHARDT LIMITED]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLARITHROMYCIN TABLET, FILM COATED [WOCKHARDT LIMITED]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PCLARITHROMYCIN TABLET, FILM COATED [WOCKHARDT LIMITED]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCLARITHROMYCIN TABLET, FILM COATED [WOCKHARDT LIMITED]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLARITHROMYCIN TABLET, FILM COATED [WOCKHARDT LIMITED]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLARITHROMYCIN TABLET, FILM COATED [WOCKHARDT LIMITED]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACLARITHROMYCIN TABLET, FILM COATED [WOCKHARDT LIMITED]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CLARITHROMYCIN TABLET, FILM COATED [WOCKHARDT LIMITED]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CLARITHROMYCIN TABLET, FILM COATED [WOCKHARDT LIMITED]2
TALCINACTIVE INGREDIENT7SEV7J4R1UCLARITHROMYCIN TABLET, FILM COATED [WOCKHARDT LIMITED]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCLARITHROMYCIN TABLET, FILM COATED [WOCKHARDT LIMITED]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55648-949CLARITHROMYCIN TABLET, FILM COATED [WOCKHARDT LIMITED]2Legacy NDC, 2 package rows20130812_3fed77ce-ad29-48e2-a28b-6d1501d0b090.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197516clarithromycin 250 MG Oral TabletPSN3fed77ce-ad29-48e2-a28b-6d1501d0b0902
197517clarithromycin 500 MG Oral TabletPSN3fed77ce-ad29-48e2-a28b-6d1501d0b0902
197516clarithromycin 250 MG Oral TabletSCD3fed77ce-ad29-48e2-a28b-6d1501d0b0902
197517clarithromycin 500 MG Oral TabletSCD3fed77ce-ad29-48e2-a28b-6d1501d0b0902

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55648-949-015564809490160 in 1 BOTTLEHistorical
55648-949-02556480949021200 in 1 POUCHHistorical